Monday, June 13, 2016

Shorter, more concise informed consent materials can help patients make fully-informed decisions about clinical trial participation without sacrificing any of the essential information required by institutional review boards (IRBs), according to recent research from Carnegie Mellon University, based in Pittsburgh, Pennsylvania, and Dublin, Ireland-based Icon.

The results, published in Medical Decision Making, support a growing movement to improve the informed consent process across the clinical trials industry. The research is consistent with the concept of “patient-centered care, whereby patients actively participate and incorporate their preferences into medical decisions,” said Dr. Tamar Krishnamurti, assistant research professor, Engineering & Public Policy, Carnegie Mellon, and study co-author.

“It is a long-standing, well-known issue that informed consent documents have become increasingly complex, long and difficult to understand,” said Dr. Jamie Brehaut, senior scientist, Ottawa Hospital Research Institute. These findings mark a start to a discussion about what should be included in informed consent documents in general, said Brehaut, who was not involved in the research.

The concept underlying this research is that patients presented with straightforward, concise consent documents, “may feel more engaged in the consenting process and may be more likely to carefully read the information,” said Krishnamurti. As a result, these patients may be able to make more fully informed decisions, she said.

To test this hypothesis, researchers designed two sequential studies. In the first study, asthma patients were asked to take a survey in which they identified concepts most important to their decision-making process around trial enrollment. Based on those survey results, researchers revised the original, 17-page consent form into a five-page document and a 10 minute, 33 second video describing the informed consent process.

The second study—in which patients were asked to consider enrolling in a hypothetical asthma trial—demonstrated that patients who used the shorter document or video were more engaged in the process than those who read the 17-page consent form. In addition, the shorter formats did not negatively impact other variables such as comprehension, feelings of trust or assessment of risks and benefits.

“The shorter form is getting patients the information that they want in a form they can process,” explained Dr. Nichole Argo, research scientist, Engineering & Public Policy, Carnegie Mellon, and study co-author. However, longer consent forms may provide some intrinsic value in terms of liability or reporting obligations to an IRB. As such, all study participants had access to the 17-page form. In future studies, rather than omitting longer forms completely, patients could be given the option of moving through the consent process with shorter, patient-friendly materials, Argo explained.

Overall, the study is a “nicely designed piece of work” in which first results aptly informed the ultimate comparative analysis, said Dr. Rebecca Ryan, deputy coordinating editor of Cochrane Consumers and Communication Review Group in Melbourne, Australia. The design allowed patients to weigh in on valuable components of their decision-making process, explained Ryan, who was not involved in the research.

One interesting find, Ryan said, was that repetition of concepts in the longer, 17-page form did not necessarily help patients comprehend the material. “More is not always better,” she said. In fact, identifying the “core essential bits of information” likely diminishes the risk that patients will become overwhelmed by pages and pages of materials, agreed Brehaut.

In addition to condensed written material, video was also an important component of the comparative trial design. Video participants ranked “physician trust” significantly higher than those in the shorter-document group. Trust is a predictor of enrollment, Argo said, although in this case increased trust among the video group did not directly translate into a greater willingness to enroll in the hypothetical trial.

Still, because of the already well-established connection between visual media and information retention, multimedia consent formats could “empower people in a completely different way,” said Frances Abeton, VP of Firecrest, Icon.

“To me, this is a new way of communication in the clinical trials industry,” said Abeton. Despite the hefty compliance demands on the industry, Abeton believes that media elements can not only help simplify the process, but also increase compliance.

The next logical step, Argo said, is to evaluate whether shorter-form compliance documents have any effect on trial dropout rates in a real clinical trial context. Better comprehension and engagement from the start of the trial could offset the risk that a patient will later drop out, Argo explained.

Creating shorter documents or multimedia consent materials is only part of the larger challenge of developing a process that helps patients make better decisions, cautioned Brehaut. From a societal standpoint, an improved consent process will leave patients with “a positive impression of the health research enterprise,” said Brehaut.

There seems to be very little downside to shorter, more comprehensible consent materials, researchers agreed. It’s even possible that a simplified consent process could improve retention rates in clinical trials, Argo said, and from an ethical perspective, “it’s the right thing to do.”

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